Tokyo, Feb. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060693) titled 'Frequency and Intake Study after Post-Egg Oral Food Challenge' on Feb. 17.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - NHO Sagamihara National Hospital
Condition:
Condition - Food allergy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the efficacy of frequent low-dose versus standard-dose home intake of heated egg by evaluating symptom occurrence at 1/2 egg OFC after 6 months in children who tested negative for 1/8 egg OFC.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Tamakona(R) 250 three times per week for 6 months.
Interventions/Control_2 - Tamakona(R) 750 once per week for 6 months.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - 18
years-old
>=
Gender - Male and Female
Key inclusion criteria - Patients with a history of immediate-type allergic reactions to hen's egg
Patients who had a negative oral food challenge (OFC) to 1/8 of a heated hen's egg at our hospital OR Patients who had a positive OFC to 1/2 of a heated whole egg at our hospital
Patients (or their guardians) who provided written informed consent for participation in the study
Key exclusion criteria - Patients with severe comorbidities (e.g., severe asthma, cardiac disease)
Patients scheduled to receive other allergy treatments (e.g., oral immunotherapy) during the study period
Patients deemed inappropriate for study participation by the principal investigator
Target Size - 104
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 03 Month 28 Day
Date of IRB - 2025 Year 03 Month 28 Day
Anticipated trial start date - 2026 Year 02 Month 17 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069423
Disclaimer: Curated by HT Syndication.